UMIN-CTR Clinical Trial

Basic information
Public title	Effects of BanxiaHoupuTang for swallowing disorder and prevention of aspiration pneumonia in brain damaged patients
Acronym	HT for swallowing reflex and prevention of pneumonia in brain disease
Scientific Title	Effects of BanxiaHoupuTang for swallowing disorder and prevention of aspiration pneumonia in brain damaged patients
Scientific Title:Acronym	HT for swallowing reflex and prevention of pneumonia in brain disease
Region	Japan

Condition
Condition	post cerebrovascular disease, neurodegenerative diseases e.g. PD, SCD, ALS
Classification by specialty	Medicine in general Neurology Geriatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effects of BHT for swallowing refles disorder and preventing aspiration pneumonia in brain disease patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	wallowing reflex, pneumonia onset
Key secondary outcomes	days with fever over 37.5, self-feeding

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	Taking BHT (traditional Chinese medicine) 8weeks
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	60 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	1.elderly patients with brain diseases 2.Swallowing reflex can be tested 3.Aspiration pneumonia history at least 1 time 4.Transaminases are less than twice of w.n.l. 5.Cre less than 2.0 6.Stable status and will survive more than 3 months after baseline 7.With informed concent and agreement from patients or family members
Key exclusion criteria	1.Patients having malignancy, severe heart diseases and other factors that would influence the results. 2.Chronic respiratory diseases e.g. BA, COPD 3.Without agreement of patients or family members
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yoshinobu Takemoto
Organization	Tagami memorial hospital
Division name	Internal medicine
Zip code
Address	Nisibeppucho 1779, Kagoshima City
TEL	099-282-0051
Email

Public contact
Name of contact person	1st name Middle name Last name Yoshinobu Takemoto
Organization	Tagami memorial hospital
Division name	Internal medicine
Zip code
Address	Nisibeppucho 1779, Kagoshima City
TEL	099-282-0051
Homepage URL
Email	yoshinobu_takemoto@shunpukai.com

Sponsor
Institute	Dept. of traditional Asian medicine, Postgraduate school of medicine, Tohoku University
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	National Yonezawa hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	Tagami memorial Hospital, Kagoshima Prefacture, National Yonezawa hospital, Yamagata Pref

Other administrative information
Date of disclosure of the study information	2010 Year 10 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	http://jglobal.jst.go.jp/public/20090422/201102220184329522
Number of participants that the trial has enrolled
Results	Hangekobokuto improved the swallowing refex and decrease the pneumonia onset.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 07 Month 16 Day
Date of IRB
Anticipated trial start date	2010 Year 08 Month 01 Day
Last follow-up date	2011 Year 01 Month 01 Day
Date of closure to data entry	2011 Year 02 Month 01 Day
Date trial data considered complete	2011 Year 03 Month 01 Day
Date analysis concluded	2011 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date	2010 Year 09 Month 17 Day
Last modified on	2012 Year 03 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005083

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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